Events

Recall of Tina-quant Haemoglobin A1c Gen.2 used with COBAS INTEGRA 400 plus analyser, COBAS INTEGRA 800 analyser and cobas c 501/502 modules. An in vitro diagnostic medical device (IVD).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01306-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01306-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    There is a potential for elevated recoveries from patient samples when using individual c packs of tina-quant hba1c gen.2. this phenomenon has been noticed across multiple lots when the reagent has inadvertently been frozen. this issue may lead to erroneously high hba1c results.
  • Action
    Users are to ensure the correct storage conditions of +2 to +8 °C are maintained as per IFU and if freezing was suspected, a control measurement should be performed. It was also recommended at this time to perform QC on each reagent cassette. Users are to carry out QC every 24 hr when using the cassette, and with each new cassette. If QC cannot be kept within the specified range, the respective reagent cassette should not be used for further measurement. Consider switching to the Gen.3 reagent which is less susceptible to low temperatures.

Device

Tina-quant Haemoglobin A1c Gen.2 used with COBAS INTEGRA 400 plus analyser, COBAS INTEGRA 800 ana...
  • Model / Serial
    Tina-quant Haemoglobin A1c Gen.2 used with COBAS INTEGRA 400 plus analyser, COBAS INTEGRA 800 analyser and cobas c 501/502 modules. An in vitro diagnostic medical device (IVD).Material Number: 04528123190Lots affected: AllARTG Number: 174909
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited